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pdfDocument Drafted November 2024
Form Approved
OMB Control Number: 0920-1282
Expiration Date: 06/30/2026
CDC-RFA-PS-24-0003 Support and Scale-Up of HIV Prevention
Services in Sexual Health Clinics (SHIPS) Data Entry Guide
CDC estimates the average public reporting burden for this collection of information as 56 hours annually, including the time for reviewing instructions, searching existing
data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct
or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600
Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1282)
Purpose of Guidance Document
This document provides data entry/reporting guidance to sexual health clinics (SHCs) participating in the Division of Sexually Transmitted Disease Prevention’s
(DSTDP) CDC-RFA-PS-24-0003 Support and Scale-Up of HIV Prevention Services in Sexual Health Clinics (or SHIPS).
CDC-RFA-PS-24-0003, or SHIPS, has two required strategies. Recipients must address both Strategies A and B.
• Strategy A: Strengthen clinic infrastructure and improve service delivery to address the syndemic of HIV and other STIs. There are four required activities
associated with Strategy A.
• Strategy B: Foster strategic partnerships in support of the EHE initiative. There are three required activities associated with Strategy B.
Recipients should familiarize themselves with these required strategies and activities by referring to the CDC-RFA-PS-24-0003 Notice of Funding Opportunity.
Recipients will enter planned strategy and activity implementation information into their work plans. Performance measure monitoring will help the CDC and
recipients understand where reality deviated from plans and the proximal benefit of implemented work.
This document will provide clarification on SHIPS data collection which feeds directly into SHIPS performance monitoring (for additional information on SHIPS
performance measures, see the Performance Measure Guidance document). The Data Entry Guidance document (this document) reviews how to report base
data used to calculate performance measures, covers key definitions to aid in data entry, and covers concepts related to reporting such as best practices for data
abstraction processes. The Data Entry Guidance document should be thoroughly reviewed before reporting and submitting these data through REDCap.
Overarching Responsibilities/Activities of SHIPS Collaborators
As part of SHIP’s monitoring and evaluation efforts, collaborating partners will maintain compliance with agreed-upon data reporting and data management
standards, agree to consensus schedules for reporting, and commit to ongoing data quality assurance.
Fidelity to Data Collection
Adherence to reporting guidance, data definitions and recommendations for reporting is important for assuring fidelity of data while
maintaining comparability across all participating clinics. To ensure the accuracy of data and efficiency of extraction after data submission,
recipients will use the applicable REDCap instruments. REDCap will be open for data submission at least once month prior to the submission
due date.
Further, recipients are expected to maintain SAMS and REDCap access for any persons responsible for submitting data to the CDC. Should there be changes to
staffing, recipients must notify their assigned Project Officer and Evaluation Officer so that appropriate access levels may be maintained within reporting systems.
Continuous quality improvement is of utmost importance in a clinic setting as it ensures that patient care remains at the highest standard. CDC will not require
electronic medical record (EMR) systems to be altered (recipients will have the option to indicate whether data is or is not available), however, by regularly
updating the EMR system, healthcare providers can enhance accuracy, efficiency, and overall patient outcomes. Updating the clinic EMR allows for the
incorporation of new medical knowledge and best practices, ensuring that healthcare professionals have access to the most up-to-date information when
making critical decisions about patient care.
1
Adherence to Data Security & Confidentiality Requirements
SHIPS reporting will be completed in the aggregate; no individual, patient-level records will be made available to CDC. Collaborating clinics may or may not be
affiliated with public health departments, and from this perspective are considered covered entities under HIPAA regulation. However:
“Without individual authorization, a covered entity may disclose protected health information to a public health authority that is legally authorized to
collect or receive the information for the purposes of preventing or controlling disease, injury, disability including, but not limited to reporting of
disease...and conducting public health surveillance…” (MMWR, 2003).
DSTDP programs value the principles embodied in these protections and strive to establish and maintain the highest level of performance in protecting the
confidentiality and security of all information. Aggregate data reported to CDC must not contain personal identifiers such as name, social security number, date of
birth, street address, or medical record number.
Unique, personally identified clinic visit, patient and laboratory information are critical for the success of these reporting activities at the clinic level and should be
extracted into clinic-maintained databases or a set of related tables from which aggregate reporting is exported. To do this reliably, the unique identifiers
associated with individual patients and related health events must be maintained over the full SHIPS project period.
CDC Roles/Responsibilities
Upon receipt of recipient data submissions, CDC will individually check for completeness and obvious errors or omissions, with rapid follow-up to the sender if
needed. Files received from clinics will be stored in a secure shared drive at CDC with limited access only for staff working on this initiative. Using standard data
management techniques, the clinic-level information will be merged into a single data file, resulting in a dataset including all clinics’ data for a particular reporting
period. This dataset will be further checked and reviewed prior to analysis, to identify any issues that require follow-up with recipients.
Substantial involvement by CDC collaborators include:
• Facilitation of routine communications
• Provision of infrastructure for secure transport and storage of aggregate reports to CDC
• Provision of technical assistance and training (limited, targeted)
• Summary and aggregate reporting to CDC leadership, clinic collaborators and external stakeholders
Clinic-Based Data Aggregation Activities
Collaborating sexual health clinics are expected to have (or to develop) the capacity to extract record-level data from existing clinic health record systems for
aggregating patient visit and laboratory data. Clinics are expected to develop their own local processes to manipulate, map and re-code data from their EHR/EMR
into new variables for aggregate reporting at specified frequencies. Clinics will be responsible for creating tables, maintaining an archive of required datasets for
reporting using locally available resources (Excel, SAS, Access, SPSS, SQL, etc.), and running simple pivots/frequencies needed to produce data for aggregate
reporting back to the CDC.
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Sexual Health Clinic Data Management
Each sexual health clinic will likely have different electronic health records and have data systems that have been developed and modified over time to fit their
particular clinical practice environment. No single solution will fit the data management requirements across all reporting sexual health clinics. However, to
successfully complete reporting for SHIPS, recipients will likely need to maintain at minimum two master datasets at the local level.
1) Visit table: Visit-level records in the clinic's EHR will populate this table. This table will include all visits that occurred within the reporting period. A
departure from EHE Component C, this table will be used to collect information on patient visit volume, STI test volume, and HIV test volume.
2) Patient table: The primary source for reporting is a list of the unique persons who visited the clinic at least once during the reporting period. Some
patients will have multiple visits and you will need to use the patient ID (medical record number, client ID, patient ID, etc.) to develop a list/panel with a
single row for each patient.
Some data (e.g., PrEP referral/utilization) may come from separate record-keeping systems and clinics would use the patient ID or name to merge into a
single record for each patient. This high-level scheme is diagrammed below.
Reporting Schedule
Here below recipients will find the SHIPS reporting frequency and data submission schedule, by REDCap instrument.
Reporting Frequency & Data Submission Schedule
Recipients should carefully review the table below and set a reminder for the reporting periods referenced. CDC will send specific guidance to recipients ahead of
each major reporting deadline.
3
PS24-0003 (SHIPS) Instrument Reporting Schedule
Note: If the reporting deadline falls on a weekend, slight adjustments may be made and communicated to recipients as needed.
Instrument
Frequency of Reporting to the
CDC
STD-QCS
Assessment
Collected annually with the
first submission being the
most extensive to complete.
Collected annually.
Annual
Performance
Measures
Biannual
Performance
Measures
Annual
Partnerships
Collected biannually.
Collected annually, as needed.
Platform to be
Used to Report
to CDC
REDCap
When Report Due to CDC
Reporting Note
Due at application submission and
9/1 annually beginning 9/1/25.
REDCap
Due annually beginning 9/1/25.
Recipients will receive a copy of their previous
year’s submission to aid in data entry for the
current year.
Look-back period of one year.
REDCap
First biannual collection to occur
3/1/25 with subsequent
submissions due 9/1 and 3/1 of
each year.
REDCap
9/1 annually if changes are present
beginning 9/1/25.
9/1 submissions will use a look-back period of
January 1 to June 30.
3/1 submissions will use a look-back period of
July 1 to December 31 (with the exception of
the first submission occurring on 3/15/25).
Collection only triggered if recipients indicate
a change in partnerships.
4
STD-QCS:
The Recommendations for Providing Quality Sexual health clinical Services (or STD QCS) is the roadmap that bolsters SHIPS. The STD-QCS highlights the services
healthcare settings can offer to provide the highest-quality STD care to their patients. The recommendations are designed to go hand-in-hand with the STI
Treatment Guidelines – STD QCS can help guide clinical operations, while the Treatment Guidelines focus on the clinical management of patients. Healthcare
professionals can use the recommendations to identify opportunities to build, maintain, or enhance the delivery of their services.
The National Association of County and City Health Officials, or NACCHO, in partnership with the CDC, created the Planning Toolkit for Using CDC’s
Recommendations for Providing Quality Sexually Transmitted Diseases Clinical Services, which operationalizes CDC’s STD-QCS by guiding clinical settings through
assessing their currently offered STD services. It provides tools and resources for supporting decision-making regarding additional service provision for addressing
identified service gaps.
The STD QCS comprises recommendations that are separated into eight service categories. Clinics will use the assessment tool and assessment summary to
review and document in REDCap which of the services outlined in the STD QCS are or are not provided in clinic. Recipients should note that a screenshot of the
STD-QCS instrument is provided on the left-hand side of the pages that follow while key definitions are to the right. STD-QCS definitions are associated with
MMWR guidance and as such are set until or if guidance is updated.
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If ‘No’ is selected for any service, a select all
that applies picklist will appear. Recipients
may then select reasons the service is not
provided in clinic.
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Brief single STD/HIV prevention counseling session (up to 30
minutes): Brief prevention counseling is conducted in a single
session using strategies, such as motivational interviewing and
building rapport, and includes patient circumstances and needs in
the counseling plan. Moderate-intensity and high-intensity
behavioral counseling is contact time of 30–120 minutes and ≥2
hours, respectively.
Moderate-intensity STD behavioral counseling (≥30 minutes): Brief
prevention counseling is conducted in a single session using
strategies, such as motivational interviewing and building rapport,
and includes patient circumstances and needs in the counseling
plan. Moderate-intensity and high-intensity behavioral counseling is
contact time of 30–120 minutes and ≥2 hours, respectively.
High-intensity STD behavioral counseling (≥2 hours): Brief
prevention counseling is conducted in a single session using
strategies, such as motivational interviewing and building rapport,
and includes patient circumstances and needs in the counseling
plan. Moderate-intensity and high-intensity behavioral counseling is
contact time of 30–120 minutes and ≥2 hours, respectively.
Risk assessment, education and referral or link to HIV care for preexposure prophylaxis (PrEP) for HIV prevention: Provided by a
clinician or other appropriately trained staff.
Risk assessment, education and referral or link to HIV care for nonoccupational post-exposure prophylaxis (nPEP): Provided by a
clinician or other appropriately trained staff.
Emergency contraceptive pills: If emergency contraceptive pills are
not available on site or by prescription, patients can be advised that
levonorgestrel emergency contraceptive pills are available over the
counter and ulipristal acetate emergency contraceptive pills are
only available by prescription. Emergency contraceptive pills should
be taken as soon as possible within 5 days of unprotected sex.
7
On-site condom provision: Providers can partner with local
organizations, such as the local health department and communitybased organizations, to procure condoms. In some states,
prescriptions can be written for condoms. For certain settings, such
as family planning clinics, condoms should be available on-site.
Provision of PrEP for HIV prevention: Specialized STD Care: PrEP
should be available in starter packs or by prescription with on-site
follow-up care for specialized STD care. If PrEP is not provided,
navigator-assisted referral for PrEP should be provided with first
appointment made while the patient is on site.
Provision of nPEP of HIV: Specialized STD Care: nPEP starter pack
(3–7 days of medication) should be available on site, with either
on-site follow-up care or referral to specialized STD care. nPEP
complete 28-day course should be available by prescription, with
either on-site follow-up care or referral, with first appointment
made while the patient is on site. Provision of the complete 28-day
nPEP medication supply at the initial visit rather than a starter pack
of 3–7 days has been reported to increase likelihood of adherence,
especially when patients find returning for multiple follow-up visits
difficult.
8
Proctitis: Evaluation for proctitis might include visual examination
of the anus, anorectal examination with a rectal swab, digital
anorectal exam, or anoscopy. For specialized STD care, highresolution anoscopy might be included.
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At the time of patient visit: "At the time of patient visit" refers to
providing a service the same day of the patient encounter. The
intent is for a patient to receive test results prior to the
conclusion of a clinic visit to ensure same day diagnosis and
initiation of treatment as needed.
Test for trichomoniasis: On-site test for trichomoniasis can
include wet mount microscopy and OSOM® Trichomonas.
Test for bacterial vaginosis: On-site test for bacterial vaginosis can
include wet mount microscopy, OSOM® BVBlue®, and Affirm™.
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Test for vulvovaginal candidiasis: On-site test for vulvovaginal
candidiasis can include wet mount microscopy.
Gonorrhea antimicrobial susceptibility testing: Access needs to be
established for transport medium that adequately maintains the
viability of Neisseria gonorrhoeae until the specimen reaches a
laboratory (e.g., transport medium in transport container,
transport system, or transport swab). Providers should contact
their state or local health department if they have concerns about
resistant N. gonorrhoeae infection or if assistance is required for
culture and antimicrobial susceptibility testing.
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13
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Gonorrhea: Providers might not receive reimbursement for oral
medications without an on-site pharmacy. Providers can partner
with local organizations, such as the local health department and
community-based organizations, to procure oral medications or
refer patients to local organizations.
Chlamydia: Providers might not receive reimbursement for oral
medications without an on-site pharmacy. Providers can partner
with local organizations, such as the local health department and
community-based organizations, to procure oral medications or
refer patients to local organizations.
Nongonococcal urethritis: Providers might not receive
reimbursement for oral medications without an on-site pharmacy.
Providers can partner with local organizations, such as the local
health department and community-based organizations, to
procure oral medications or refer patients to local organizations.
Syphilis: Providers can partner with local health departments to
procure injectable benzathine penicillin G or refer patients to local
health department and verify treatment.
15
Emergency contraceptive pills: If emergency contraceptive pills
are not available on-site or by prescription, patients can be
advised that levonorgestrel emergency contraceptive pills are
available over the counter and ulipristal acetate emergency
contraceptive pills are only available by prescription. Emergency
contraceptive pills should be taken as soon as possible within 5
days of unprotected sex.
16
EPT for gonorrhea and chlamydia: Information on the legal status
of EPT for each state is available at
https://www.cdc.gov/std/ept/legal/default.htm.
17
EPT for gonorrhea and chlamydia: Information on the legal status
of EPT for each state is available at
https://www.cdc.gov/std/ept/legal/default.htm.
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19
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21
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Partner services: Partner services consist of various strategies with
differing levels of time and effort to enable persons who are exposed to
an STD to be identified, tested, and treated. (Refer to the 'Partner
Services' section of the Recommendations for additional information.)
Guidance regarding notification and care of sex partners: Guidance
regarding notification and care of sex partners is described as providers
giving how-to information to their patients about the need to notify their
sex partner(s) of the exposure, the need for sex partner(s) to seek care
and treatment even if they do not have symptoms, and where partner(s)
could go for STD care. (Refer to the 'Partner Services' section of the
Recommendations for additional information.)
EPT (where legal and where local or state jurisdictions do not prohibit by
regulation): Expedited Partner Therapy (EPT), also termed patientdelivered partner therapy (PDPT), is the clinical practice of treating the
sex partner(s) of persons who receive chlamydia or gonorrhea diagnoses
by providing medications or prescriptions to the patient. Patients then
provide partner(s) with these therapies without the health care provider
having examined the partner(s) (see www.cdc.gov/std/ept).Information
on legal status of EPT for each state is available at
http://www.cdc.gov/std/ept/legal/default.htm.
Interactive counseling for partner notification: In interactive counseling,
the provider and patient both actively participate in an individualized plan
to notify the patient’s sex partner(s). Interactive counseling typically is
conducted by staff with specific training or skills in communication,
interviewing, or counseling. The patient provides information about their
sex partner(s) and develops a plan with the counselor to notify partner(s).
DIS: A disease intervention specialist (DIS) is a public health professional
with applied expertise in client-centered interviews; partner services that
include contact tracing, directly observed therapy, field specimen
collection, and field investigation in outbreaks; and navigation of health
care systems to ensure patient evaluation and treatment, among other
areas. (Refer to the 'Partner Services' section of the Recommendations for
additional information.)
Express/Fast Track Model: Express/Fast Track Visits Conducted: In express services,
asymptomatic patients are routed to a less intensive testing-only experience through
standing orders and no physical examination. Please see the PS-24-0003 NOFO for core
elements of express/fast track models.
Health department DIS elicitation of sex partner information to identify
those who might have been exposed and to identify patient follow-up
needs: Partner services can be provided on site or by referral.
23
Annual Performance Measures
The Annual Performance Measure instrument is meant to collect primarily qualitative information about recipient activities conducted under SHIPS.
The information gathered in this instrument links to the recipient work plan. The work plan thoughtfully describes what activities you are planning,
how you will accomplish those activities, and how these activities will contribute to your success. The work plan can be used as a planning tool for
you and as a resource as you continue to implement project activities. This will also be used by your Project Officer to help monitor progress towards
the planned activities/sub-activities and provide technical assistance for any anticipated challenges. The Annual Performance Measures instrument is
a continuation of the work plan and is where you will report on the “impact” of implemented work under SHIPS. For the purposes of this cooperative
agreement, we will define “impact” broadly (see below).
“Impact”: Impact refers to the tangible or intangible change or effect that results from an action, decision, or
program. It could be positive or negative, direct or indirect, and can be observed in various areas such as behavior,
knowledge, conditions, or systems. In an informal context, impact is about understanding the difference a specific
action or effort makes in the real world, even if it's not measured through rigorous evaluation methods.
24
HIV and STI service integration strengthens clinic infrastructure and enhances
the provision of comprehensive sexual health services in an existing clinic to
address the syndemic of HIV and other STis. Syndemics are epidemics that
interact with each other and by that interaction increase their adverse effects
on the health of communities that face systemic, structural, and other
inequities. Holistic, coordinated care is a hallmark of the syndemic approach.
Activities under this NOFO will support a syndemic approach that is essential
to providing patients comprehensive sexual health care in clinic settings
where they routinely receive care.
Broadly defined, social determinants of health are non-medical factors that
influence health outcomes. They are the conditions in which people are born,
grow, work, live, and age, and the wider set of forces and systems shaping the
conditions of daily life. These forces (e.g., racism, climate) and systems
include economic policies and systems, development agendas, social norms,
social policies, and political systems.
Recipients should collaborate with the National Network of STD Clinical
Prevention Training Centers (NNPTC) to identify training, technical assistance,
and capacity-building opportunities to implement quality sexual health
services at the participating clinic in accordance with the STD QCS. Emphasis
should be placed on the identification of training needs to support the
provision of culturally sensitive, trauma-informed, patient-centered care.
Recipients will enter information about each training, technical assistance,
and/or capacity-building event completed in the reporting period.
Additional information and context can be found in the SHIPS (PS-24-0003)
NOFO.
25
Recipients should establish strong working relationships with the National
Network of STD Clinical Prevention Training Centers (NNPTC) for training
and capacity-building support. Recipients should collaborate with a
regional Prevention Training Center (PTC) to implement and promote
quality sexual health services in their clinics in accordance with the STD
QCS.
Additional information and context can be found in the SHIPS (PS-24-0003)
NOFO and at the following website:
https://www.cdc.gov/sti/php/projects/nnptc.html
26
Recipients will identify and propose evidence-based or evidence-informed
approaches or emerging strategies to implement at the participating clinic
that will improve patient flow, increase patient volume, and allow clinic
staff to serve patients more efficiently, including the provision of timely
testing and treatment.
Evidence-based interventions: Demonstrated effectiveness at
improving the care and treatment of people with HIV, or at-risk of
HIV. Published research evidence supporting these interventions
meets CDC criteria for being evidence-based. (Adapted from
Psihopaidas et al., 2020).
Evidence-informed interventions: Demonstrated effectiveness at
improving the care and treatment of people with HIV, or at-risk of
HIV. Published research evidence meets HRSA (and potentially
CDC) evidence-informed criteria but does not meet CDC criteria
for evidence-based interventions. (Adapted from Psihopaidas et
al., 2020).
Emerging strategies: Demonstrated effectiveness at improving the
care and treatment of people with HIV, or at-risk of HIV.
Innovative strategies that address emerging priorities for
improving the care and treatment of people with HIV or those at
risk for HIV. Real world validity and effectiveness have been
demonstrated, but emerging strategies do not yet have sufficient
published research evidence. (Adapted from Psihopaidas et al.,
2020).
Under A2, clinics are expected to implement or expand an express service
model. In express services, asymptomatic patients are routed to a less
intensive testing- only experience through standing orders and no physical
examination. While express service models vary, there are several core
elements seen across models:
•Triage to route patients to either an express visit or a traditional provider
visit
•No physical examination during an express visit
•Patient self-collects specimens, including swabs and urine, while a nurse,
DIS or phlebotomist collects blood
•Aided by technology/automation for triaging, faster lab turnaround
times, and notification of results
•Reliance on diverse staffing to allow healthcare professionals to work at
the top of their licenses (i.e., task-shifting)
Additional information and context can be found in the SHIPS (PS-24-0003)
NOFO.
27
Recipients are expected to actively participate in existing local HIV
planning activities including but not limited to engagement with existing
EHE advisory groups or committees, HIV care continuum consortiums or
Ryan White HIV/AIDS program planning councils/bodies, PrEP coalitions,
and rapid start collaboratives (for PrEP and/or HIV care) in their
jurisdiction. Recipients are expected to use input obtained through
participation in local HIV planning activities to improve the quality of
clinical care and clinic experience in their participating clinic, and to focus
on their priority population(s).
What is the difference between activity B1 and B2? The distinction
between B1 and B2 lies in the fact that B1 primarily emphasizes the
recipient's responsibility to delineate the necessary steps for establishing
partnerships with specific organizations for well-defined projects, while B2
is oriented towards more broader-based coalition-building efforts. HIV
planning entities might have looser charges and might be more focused
on ensuring a referral network is in place. Further, participation in HIV
planning efforts will help ensure that individual member organizations are
not providing redundant services but that rather member organizations
leverage one another’s niches and specialties.
What is the difference between activity B3 and A3? A3 is primarily
centered around the collection of information from patients who are
currently receiving medical care at the clinic. On the other hand, B3 is
specifically dedicated to obtaining input from priority populations that
may not be adequately reached or engaged within the clinic setting. The
objective is to identify strategies for bridging this gap by directly engaging
with priority populations to understand what might motivate them to
seek care at the clinic, to better understand messaging that may resonate
and other relevant factors.
Additional information and context can be found in the SHIPS (PS-240003) NOFO.
28
Recipients are expected to build active and meaningful engagements with
the communities of priority populations affected by HIV and other STIs to
inform clinic sexual health service delivery improvements and advance
health equity. Clinics should tailor their community engagement (CE)
activities to available resources, training, expertise, and the priority
populations identified in their application. Community engagement: The
process of working collaboratively with and through groups of people to
improve the health of the community and its members. Community
engagement often involves partnerships and coalitions that help mobilize
resources and influence systems, improve relationships among partners,
and serve as catalysts for changing policies, programs, and practices.
Additional information and context can be found in the SHIPS (PS-240003) NOFO.
29
Partnerships (Initial & Annual)
CDC expects recipients to foster strategic community partnerships with providers, community- based organizations, and health departments to maximize the
impact of EHE implementation and improve equitable access to HIV and sexual health services. Using Partnership instruments, recipients can describe how their
community partners serve their priority population(s).
Recipients will complete an initial Partnership Instrument which will be updated annually if changes occur.
30
Initial Partnerships
Recipients should identify the highest priority collaborations to focus on in
Year 1. For each existing and new collaboration, recipients must describe 1)
the extent of the current collaboration with the entity, 2) the specific
objectives of the partnership for the purposes of implementing strategies
and activities in this NOFO, 3) plans for strengthening or maintaining
that collaboration in Year 1, and 4) any funding or sharing of resources that
the clinic proposes to give the partner organization.
Additional information and context can be found in the SHIPS (PS-24-0003)
NOFO.
31
32
Annual Partnerships (Updates Y2-5)
This form will only be triggered if recipients indicate a change in partnerships.
If a change is indicated, this form will appear wherein recipients may update
their partnership list accordingly.
33
Biannual Performance Measures
Unless stated otherwise, all reporting categories should be reported using the qualifier “as of the end of the reporting period.” In other words, if CDC requests
the total number of unique persons testing positive for HIV, this is to mean that CDC is interested in the total number of unique persons testing positive for HIV as
of the end of the specified reporting period. If a unique individual tests negative at the start of the reporting period and seroconverts during the reporting period,
use the most up-to-date categorization as of the end of the reporting period.
34
Volume of Visits Conducted in the Reporting Period-Total Number of Visits:
Visits documented here need not be per unique patients. Rather, we are
looking for total visit numbers. Do not include encounters with persons
outside of the clinic (e.g., community-based services) that are not
documented on an individual basis in your clinic’s medical records system
(information about community activities will be collected elsewhere).
Volume of Tests Conducted in the Reporting Period-Total Number of Tests
Conducted: Includes all STI (syphilis, chlamydia, gonorrhea, mpox) tests that
are supported in any way by EHE (e.g., funding, test kits, personnel, training
and technical assistance, laboratory support) or other resources available to
the clinic so long as results are obtained in or reported to the clinic. Report all
tests here, not the number of persons tested. Includes all negative and
positive test results in the budget period. Walk-in testing at a partner lab
would be counted here if a medical record is generated at the clinic during
the report period AND the results (both negative or positive) are reported by
the laboratory to the clinic to drive routine care.
Total Number of Tests Conducted for HIV: Includes all HIV tests
(antibody, antigen/antibody, NAT) that are supported in any way by
EHE (e.g., funding, test kits, personnel, training and technical
assistance, laboratory support) or other resources available to the
clinic so long as results are obtained in or reported to the clinic.
Volume of Cases Diagnosed in the Reporting Period-Total Number of Cases
Diagnosed: Please enter the total number of new STI cases identified
(syphilis, gonorrhea, chlamydia, and mpox), in the specified reporting period.
This may include cases diagnosed in any previous reporting period and
reinfected, then diagnosed in this reporting period. Please count only cases
with a positive test AND confirmed clinical diagnosis.
Volume of Cases Treated in the Reporting Period-Total Number of Cases
Treated: Please enter the values of the total number of STI cases identified
receiving CDC-recommended treatment for syphilis, gonorrhea, chlamydia,
and mpox in the specified reporting period. This may include cases treated in
any previous reporting period and reinfected, then diagnosed and treated in
this reporting period. CDC’s recommendations for treating STIs are outlined in
the 2021 STI Treatment Guidelines.
Volume of Vaccines Administer in the Reporting Period-Total Number of mpox
vaccines administered: Please enter the total number of mpox vaccines
(either Jynneos, ACAM2000, or a commercial alternative) administered in the
reporting period.
35
Race/Ethnicity: Race and ethnicity are to be collected at the local level
in accordance with OMB standards and reported to the CDC in the
aggregate using these standards. The Office of Management and Budget
(OMB) announced revisions effective as of March 28, 2024, to Statistical
Policy Directive No. 15: Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity (SPD 15). The revised SPD
15 replaces and supersedes OMB’s 1997 Revisions to the Standards for
the Classification of Federal Data on Race and Ethnicity. SHIPS will
comply with this directive by utilizing the below minimum categories for
data on race and ethnicity. Respondents shall be offered a single
combined race and ethnicity question that allows them to select one
category or multiple categories. A single selection will be considered a
complete response (e.g., Hispanic or Latino respondents are not
required to select an additional category).
American Indian or Alaska Native. Individuals with origins in
any of the original peoples of North, Central, and South
America, including, for example, Navajo Nation, Blackfeet Tribe
of the Blackfeet Indian Reservation of Montana, Native Village
of Barrow Inupiat Traditional Government, Nome Eskimo
Community, Aztec, and Maya.
Asian. Individuals with origins in any of the original peoples of
Central or East Asia, Southeast Asia, or South Asia, including,
for example, Chinese, Asian Indian, Filipino, Vietnamese,
Korean, and Japanese.
Black or African American. Individuals with origins in any of the
Black racial groups of Africa, including, for example, African
American, Jamaican, Haitian, Nigerian, Ethiopian, and Somali.
Hispanic or Latino. Includes individuals of Mexican, Puerto
Rican, Salvadoran, Cuban, Dominican, Guatemalan, and other
Central or South American or Spanish culture or origin.
Middle Eastern or North African. Individuals with origins in any
of the original peoples of the Middle East or North Africa,
including, for example, Lebanese, Iranian, Egyptian, Syrian,
Iraqi, and Israeli.
Native Hawaiian or Pacific Islander. Individuals with origins in
any of the original peoples of Hawaii, Guam, Samoa, or other
Pacific Islands, including, for example, Native Hawaiian,
Samoan, Chamorro, Tongan, Fijian, and Marshallese.
White. Individuals with origins in any of the original peoples of
Europe, including, for example, English, German, Irish, Italian,
Polish, and Scottish.
For additional information about SPD 15, please visit spd15revision.gov
36
Population group: As applicable to the recipient’s priority
population and/or available data, please enter numbers of
persons who fall into population group categories.
Age Group: Age reporting is fairly straightforward, though “edge”
issues for age reporting come up (when people have a birthday
during the report period that puts them in a different age
category by the end of the reporting period). For activities
funded through SHIPS (e.g., PrEP referrals, HIV testing), use “as of
the end of the report period” to guide reporting. In other words,
take the fictional character Sheldon Plankton as an example.
Sheldon was 29 years of age when he first tested positive for HIV,
but by the end of the same reporting period, he would be 30. As
such, Sheldon should be reported in the 30-65 age group for this
reporting period.
37
Sex at birth: Sex is a multidimensional construct based on a
cluster of anatomical and physiological traits (sex traits). Sex at
birth definitions can be found here below.
Male: Male sex assigned at birth on an individual’s birth
certificate.
Female: Female sex assigned at birth on an individual’s
birth certificate.
Intersex. Individuals born with sexual anatomy,
reproductive organs, and/or chromosome patterns that
do not fit the definition of male or female.
Gender: Gender is a multidimensional construct that links gender
identity, gender expression, and social and cultural expectations
about status, characteristics, and behavior that are associated
with sex traits.
Please refer to the Recommendations on the Best Practices for
the Collection of Sexual Orientation and Gender Identity Data on
Federal Statistical Surveys located here:
https://www.whitehouse.gov/wpcontent/uploads/2023/01/SOGI-Best-Practices.pdf
38
Please refer to the Recommendations on the Best Practices for
the Collection of Sexual Orientation and Gender Identity Data on
Federal Statistical Surveys located here:
https://www.whitehouse.gov/wpcontent/uploads/2023/01/SOGI-Best-Practices.pdf
39
Number of unique persons who are HIV positive: Includes all
persons known to be HIV-positive either by self-report (with or
without prior test history at the Sexual health clinic), prior
confirmed positive HIV test or those who received a positive test
at the SHC during the reporting period.
Number of unique persons who are HIV-negative: Includes all
persons known to be HIV-negative either by self-report (with or
without prior test history at the Sexual health clinic), a prior
negative HIV test, or those who received a negative test at the
SHC during the reporting period.
Number of unique persons whose HIV status is unknown:
Includes all persons with an unknown HIV status. For the most
part, this field will capture persons who decline an HIV test in the
reporting period.
40
Number of unique persons prescribed HIV nPEP: This is the
number of people who started nPEP for HIV at least once, in the
specified reporting period. Count all persons who received one or
more prescriptions for nPEP. The number of people who received
preventive services should be a subset and cannot be greater
than the number of people served.
Number of unique persons prescribed or given doxyPEP: This is
the number of people who were prescribed or given DoxyPEP for
bacterial STIs, in the reporting period. Count all unique persons
who received one or more prescriptions for DoxyPEP.
41
SHIPS PrEP Cascade
PrEP Eligible
Referred
Prescribed
PrEP eligibility definition: Those eligible for PrEP are HIV-negative and at substantial risk
for HIV, as defined locally or by CDC guidelines for PrEP
(https://www.cdc.gov/hiv/effective-interventions/prevent/prep/index.html). CDC is
interested in capturing the operationalized clinic definition for PrEP eligibility.
Number of unique persons already on PrEP as prescribed at/by clinic [refill/maintenance]:
Includes persons with no prior HIV-positive test history, conferment HIV-negative test or
self-report of HIV-negative status in the clinic, who are documented in their medical
record as currently prescribed PrEP at/by the clinic and on appropriate monitoring in the
current reporting period. For people with PrEP refills (distinct from new in that these
imply current, ongoing PrEP use), they should not get counted multiple times in this
column but should be reflected once.
Number of unique persons referred to a PrEP provider [internally or in-house]: Persons
referred to an internal PrEP provider are HIV-negative and at risk for HIV, as defined
locally or by CDC guidelines for PrEP, or are HIV-negative and requesting PrEP. If the clinic
has a co-located PrEP provider (i.e., a CBO doing PrEP, Ryan White HIV Clinic or other
agency not fiscally related to the clinic) referral to that specific practitioner could count as
an external PrEP referral and should be recorded as an external referral.
Number of unique persons referred to a PrEP provider [externally]: Referral to a PrEP
provider external to the clinic is a process involving the provision of information on who
the providers are, what documents referred person should take with them, how to get to
the providers’ agency, and what to expect from the referral process. If the clinic has a colocated PrEP provider (i.e., a CBO doing PrEP, Ryan White HIV Clinic or other agency not
fiscally related to the clinic) referral to that specific practitioner could count as an external
PrEP referral and would be recorded here.
Number of unique persons prescribed PrEP at/by clinic [Initial Prescription]: Prescribed
PrEP refers to a person who has been adequately evaluated and received an initial
prescription for PrEP at the clinic. If an initial prescription and subsequent refill
prescriptions are provided to a patient during the same reporting period, only record the
patient in this column and not in Column D. Information may come from EHR or pharmacy
records.
42
Number of unique persons tested for HIV: This is the number of people who were tested
for HIV at least once in the specified reporting period. Do not include persons who are
known to be HIV positive and receiving confirmatory testing here. For unavailable or
missing values, please enter the applicable numbers in the ‘unknown’ fields.
Number of unique persons newly diagnosed with HIV: This is the number of persons that
are newly diagnosed and were not tested and diagnosed in a previous reporting period.
New HIV cases are the numbers of people who, at minimum, test positive after being
tested in the specified reporting period, and should not be greater than the number of
people tested. For unavailable or missing values, please enter the applicable numbers in
the ‘unknown’ fields.
Number of unique persons newly diagnosed with HIV & linked to care within 7 days of
diagnosis [internally or in-house]: CDC will be defining rapid linkage to care as meeting at
least one of the following markers within 7 days of HIV diagnosis: patient entry into
specialist HIV care measured by confirmed attendance at the first appointment, the first
CD4+ cell count or viral load date, or HIV treatment start date, depending on data
availability. Only document those rapidly linked to care internal to the clinic here.
Number of unique persons newly diagnosed with HIV & linked to care within 7 days of
diagnosis [externally]: CDC will be defining rapid linkage to care as meeting at least one of
the following markers within 7 days of HIV diagnosis: patient entry into specialist HIV care
measured by confirmed attendance at the first appointment, the first CD4+ cell count or
viral load date, or HIV treatment start date, depending on data availability. Only
document those who received a warm handoff to an external provider here.
Number of unique persons newly diagnosed with HIV though unlinked to care within 7
days of diagnosis/Lost to follow-up: CDC will be defining rapid linkage to care as meeting
at least one of the following markers within 7 days of HIV diagnosis: patient entry into
specialist HIV care measured by confirmed attendance at the first appointment, the first
CD4+ cell count or viral load date, or HIV treatment start date, depending on data
availability. Document any persons newly diagnosed with HIV who do not meet the
criteria for being rapidly linked to care (internally or externally) here.
43
File Type | application/pdf |
File Title | CDC-RFA-PS-24-0003 Support and Scale-Up of HIV Prevention Services in Sexual Health Clinics (SHIPS) Data Entry Guide |
Author | Evans, Lindsey (CDC/NCHHSTP/DSTDP) |
File Modified | 2024-11-21 |
File Created | 2024-11-21 |